FDA MedWatch - New warnings added to Bextra (valdecoxib) label

[Brian, ASN, RN]

The FDA announced important new information on side effects associated with

the use of Bextra, a COX-2 selective non-steroidal anti-inflammatory drug

(NSAID) indicated for the treatment of osteoarthritis, rheumatoid arthritis

and dysmenorrhea (menstrual pain). A "boxed" warning, strengthening previous

warnings about the risk of life-threatening skin reactions, and a new bolded

warning contraindicating the use of Bextra in patients undergoing coronary

artery bypass graft (CABG) surgery were added to the label.

Read the 2004 MedWatch safety summary, including links to the Talk Paper,

Questions and Answers, and revised label at:

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Bextra